The Pediatric HIV AIDS Cohort Study addresses two critical research questions: (1) the consequences of fetal and infant exposure to antiretroviral therapy (ART) when used to prevent mother-to-child transmission of HIV-1, and (2) the clinical course of perinatal HIV infection among children as they proceed through adolescence towards adulthood. These questions are being addressed through two separate protocols being conducted at multiple sites in the US and Puerto Rico.
The specific aim of the SMARTT Study is, among HIV-exposed infants, to define the short and long-term safety of ART exposure. To accomplish this, HIV-uninfected children born to infected mothers are evaluated prospectively for growth, neurodevelopment, cardiac and other end-organ function. Children with abnormalities will be further evaluated to determine if they result from ART toxicity, with particular emphasis on mitochondrial dysfunction.
The specific aims of AMP are, among a cohort of pre-adolescents and adolescents with perinatal HIV (1) to define the impact of HIV infection and ART on: growth and development;sexual maturation;pubertal development;development of risk factors for cardiovascular disease;cognitive, academic, vocational, sexual, and social functioning;mental health;and risk taking behavior including substance use. (2) to identify infectious and non-infectious complication of HIV disease and ART therapy, including end organ disease (neurologic, renal, pulmonary, bone) and nutritional and metabolic abnormalities. (3) to study genetic, epigenetic, virologic (including antiretroviral resistance), and immunologic factors which impact the course of HIV infection, its complications and response to treatment. In both protocols, subjects and their primary caregivers are prospectively evaluated according to a standardized protocol. Both utilize a strategy of triggered evaluations, with specific abnormal findings leading to additional evaluations to characterize the abnormality. Repository specimens are collected for further biochemical and genetic testing.

Public Health Relevance

Defining the safety of preventive ART during pregnancy - including the safety of individual drugs - is necessary to define the safest strategy to prevent mother-to-transmission of HIV. Perinatal HIV has become a chronic condition, and an understanding of the long-term outcomes of the infection and its treatment is necessary to provide care for these children.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HD052104-08
Application #
8305553
Study Section
Special Emphasis Panel (ZHD1-DSR-A (06))
Program Officer
Mofenson, Lynne M
Project Start
2005-09-30
Project End
2015-07-31
Budget Start
2012-08-01
Budget End
2013-07-31
Support Year
8
Fiscal Year
2012
Total Cost
$977,455
Indirect Cost
$285,613
Name
Tulane University
Department
Pediatrics
Type
Schools of Medicine
DUNS #
053785812
City
New Orleans
State
LA
Country
United States
Zip Code
70118
Spector, Stephen A; Brummel, Sean S; Nievergelt, Caroline M et al. (2016) Genetically determined ancestry is more informative than self-reported race in HIV-infected and -exposed children. Medicine (Baltimore) 95:e4733
Kapogiannis, Bill G; Leister, Erin; Siberry, George K et al. (2016) Prevalence of and progression to abnormal noninvasive markers of liver disease (aspartate aminotransferase-to-platelet ratio index and Fibrosis-4) among US HIV-infected youth. AIDS 30:889-98
Van Dyke, Russell B; Patel, Kunjal; Kagan, Ron M et al. (2016) Antiretroviral Drug Resistance Among Children and Youth in the United States With Perinatal HIV. Clin Infect Dis 63:133-7
Tassiopoulos, Katherine; Patel, Kunjal; Alperen, Julie et al. (2016) Following young people with perinatal HIV infection from adolescence into adulthood: the protocol for PHACS AMP Up, a prospective cohort study. BMJ Open 6:e011396
Lewis-de Los Angeles, C Paula; Alpert, Kathryn I; Williams, Paige L et al. (2016) Deformed Subcortical Structures Are Related to Past HIV Disease Severity in Youth With Perinatally Acquired HIV Infection. J Pediatric Infect Dis Soc 5:S6-S14
Guerra, Vitor; Leister, Erin C; Williams, Paige L et al. (2016) Long-Term Effects of In Utero Antiretroviral Exposure: Systolic and Diastolic Function in HIV-Exposed Uninfected Youth. AIDS Res Hum Retroviruses 32:621-7
Redmond, Sean M; Yao, Tzy-Jyun; Russell, Jonathan S et al. (2016) Longitudinal Evaluation of Language Impairment in Youth With Perinatally Acquired Human Immunodeficiency Virus (HIV) and Youth With Perinatal HIV Exposure. J Pediatric Infect Dis Soc 5:S33-S40
Malee, Kathleen M; Smith, Renee A; Mellins, Claude A et al. (2016) Brain and Cognitive Development Among U.S. Youth With Perinatally Acquired Human Immunodeficiency Virus Infection. J Pediatric Infect Dis Soc 5:S1-S5
Zash, Rebecca M; Williams, Paige L; Sibiude, Jeanne et al. (2016) Surveillance monitoring for safety of in utero antiretroviral therapy exposures: current strategies and challenges. Expert Opin Drug Saf 15:1501-1513
Nichols, Sharon L; Chernoff, Miriam C; Malee, Kathleen et al. (2016) Learning and Memory in Children and Adolescents With Perinatal HIV Infection and Perinatal HIV Exposure. Pediatr Infect Dis J 35:649-54

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